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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

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As Compounding Crisis Widens, Legislators Propose Regulatory Fixes

Posted 10 October 2012 | By Alexander Gaffney

US legislators are scrambling to get to the bottom of a burgeoning crisis involving products compounded at a Massachusetts pharmaceutical compounder's facility that have thus far killed 11 people and infected more than 100, announcing hearings and new legislation meant to plug oversight gaps in the regulatory system.

In a 9 October announcement, the House Energy and Commerce Committee said it had requested briefings from both the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) regarding the outbreak, now understood to have been transmitted by steroidal injections compounded en masse by the New England Compounding Center (NECC).

"We intend to learn more from the FDA, CDC, and others who may provide insight into the details surrounding this outbreak and the prevention of future outbreaks," wrote the committee, which oversees the pharmaceutical sector, in a joint statement. The congressmen said FDA's briefing to Congress should occur no later than Friday, 12 October 2012.

Rep. Markey Raises Specific Concerns

Other congressmen, including Rep. Ed Markey (D-MA), also a member of the Energy and Commerce Committee, expressed some specific concerns about FDA's authority to oversee compounding pharmacies.

"The growing trend of larger compounding pharmacies entering the market for the preparation and creation of high-risk drugs that require utmost sterility, such as spinal injections, raises questions about how the safeguards and high standards met by large drug manufacturing companies are being met by compounding pharmacies," wrote Markey, adding he believed the pharmacies currently reside in a regulatory "black hole."

At issue for Markey is the overlapping series of regulations and non-regulations that make it difficult for any one regulator to oversee the entire compounding sector. Though FDA asserts authority to oversee compounding, courts have periodically rejected this authority, and state governments are largely tasked with overseeing the sector. Some states exercise this authority, while others take a more hands-off approach.

This patchwork of regulations is now threatening to fail, as it did in the meningitis outbreak, and requires additional oversight, contends Markey. "If compounding is done on a large scale and is not done properly, compounders can expose large numbers of patients to health risks associated with unsafe or ineffective medications," he wrote. "In addition, compounding pharmacies circumvent important public health requirements and undermine the drug approval process-the evidence-based system of drug review that consumers and health professionals rely on for safe and effective drugs."

Markey said he was looking for answers from FDA regarding its oversight of compounders, including whether it provides guidance to state regulators, its history of inspections, its regulation of bulk ingredients used by compounders, its oversight of interstate commerce and its assessment of whether it has sufficient authority to regulate compounding pharmacies.

Legislation to be Introduced

Markey and Rosa DeLauro (D-CT), also a member of the House Energy and Commerce Committee, each respectively announced they will introduce legislation to grant regulators additional authority to oversee compounding pharmacies.

"I believe this outbreak and corresponding recall make clear that strong Federal authority is needed over these large-scale compounding pharmacies to ensure that patients receive safe and effective drugs, that we better monitor adverse events associated with these drugs, and that there is a single entity responsible for verifying appropriate marketing and safe drug production," DeLauro wrote.

Markey said his legislation would require compounding pharmacies to register with FDA, comply with good manufacturing practices and other safety standards, ban pharmacies from compounding using unapproved active pharmaceutical ingredients, explicitly define compounding pharmacies, mandate adverse event reporting, allow FDA to inspect compounding pharmacies and require compounded products to be labeled with a warning that the product has not been approved by FDA.

FDA Under Fire

The legislator's actions come as increasing public awareness of the outbreak has created an emerging firestorm of controversy. The public advocacy group Public Citizen said the outbreak, "Highlights the failure of FDA's regulatory oversight of drugs prepared and sold by such pharmacies."

"FDA failed to take actions to ensure that the New England Compounding Center adhered to these drug standards, which are essential for protecting the health of patients," it wrote. "By not aggressively enforcing regulations related to the drug manufacturing by compounding pharmacies, FDA has perpetuated a double standard [between compounders and traditional manufacturers.]

An editorial by the New York Times was more sympathetic to FDA, noting that legal precedence has left the agency's authority murky, but nevertheless called for legislation to close regulatory loopholes.

"The legislation ought to grant FDA any powers it thinks it needs to inspect compounding pharmacies, monitor their nationwide sales and judge the safety or effectiveness of their products," wrote The Times. "It should also empower FDA to block pharmacies from making drugs (such as injectable steroids) that require a higher degree of sterility than many of them can meet."

Whatever the cause, The Wall Street Journal reports doctors are certainly taking notice, and seem likely to rethink their use of compounded medicines in the wake of the crisis. "I think the whole [health-care] industry is going to undergo some serious internal rethinking," said Bonnie Levin, assistant vice president for pharmacy services at MedStar, to the WSJ.